Batch Control with zenon in the Pharmaceutical Industry

Optimize processes in batch production with zenon

Production via the batch process is standard in the pharmaceutical industry. Complete traceability, maximum product safety, consistent quality and reliability are the most important challenges that you will overcome with zenon.

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You can rely on the zenon software platform during batch-based production. zenon's Batch Control offers a fast, hardware-agnostic implementation, seamless integration and excellent user-friendliness. zenon gives you control over the entire process and assists you in optimizing production.

The system that grows with you

Thanks to the scalability and flexibility of Batch Control, you can both control individual processes and the entire production system in zenon. Extension of the equipment is no problem either. For instance, start with an isolated process and gradually expand the system to one or several batch processes and then to a homogeneous and fully integrated environment – including a cloud connection, reporting, mobile solutions and much more. Thanks to the numerous interfaces, you can connect various hardware and software.

zenon is independent. Thanks to the various drivers, you can connect many different industrial systems, equipment, machines and measuring equipment, no matter which manufacturer and irrespective of whether it already exists or is new. It provides you with a holistic view of the entire production process.

Even existing control and monitoring systems can be integrated into zenon and thus, enhanced because zenon adds technologies and functions to an existing system without having to change, upgrade or revalidate them.

Flexible to use

Using zenon for batch production is also perfect for efficiently producing small quantities of various pharmaceutical products with one set of equipment. As soon as the system is validated once, you can change recipes on this basis without the need for revalidation. This allows for a quick and economical conversion to each new product. Result: Your production becomes more flexible and profitable.

Quick reports

Thanks to the full integration of the batch process, production data is simultaneously recorded and analyzed. This provides the necessary reports for immediately approving the batch after the process has finished. The interplay between automated and manual processes is not an issue with Batch Control in zenon. Staff can manually enter parameters in the system while the automated processes are connected via interfaces. This lets you manually and automatically analyze the collected data in parallel. Operators benefit from a graphical interface with high usability which, for example, is operated via a touchscreen on tablets.

This saves time and money since products are put to market more quickly, and it prevents analysis errors that can happen during entirely manual processes. You furthermore benefit from analysis tools and numerous reporting options in zenon. By doing so, you increase the benefit and get even more out of your existing system.

ERP and batch – IT and OT grow together

zenon uses native interfaces to integrate with ERP systems. This allows for a smooth flow of data between ERP and batch execution, making manual intermediate steps redundant. It creates a homogeneous environment, where batch production can be executed securely and efficiently.

Guaranteed compliance

zenon complies with international regulations such as FDA 21 Part 11 and EU Annex 11. Compliance is achieved only via configuration and without programming, as specified by Category 4 of the ISPE GAMP5 guideline. Configurability not only allows for compliance but also makes it as simple and efficient as possible. This saves time and costs during implementation, maintenance and expansion and prevents errors during project configuration.

zenon Batch Control is ISA 88-compliant and separates the process from the operational level. Recipes or even hardware components can therefore be changed without affecting the automation. This opens up perspectives for innovations, since recipes can be flexibly adapted without revalidation.